Argument recap: Analogies to the rescue

Posted Mon, April 15th, 2013 1:17 pm by Lyle Denniston

Analysis

It is a natural human trait — of judges, too — when one doesn’t quite grasp a very complex idea, to reach for something commonplace for comparison. For the nine Justices of the Supreme Court, imperfectly versed in biochemistry, it was most useful on Monday to talk about how a baseball bat gets created, and how the sap of a plant in a forest in the Amazon might be analyzed for its powers to cure human disease. But those very analogies strongly suggested that an inventor probably cannot get a patent for taking something out of the human body, and manipulating it without changing its nature.

Throughout a sometimes achingly complex argument over bio-science, the down-to-earth images of shaping a bat out of a tree limb, or swallowing the sap of an Amazon plant to test its medicinal value appeared to put the Court closer to resolving a truly fundamental issue of patent law, on the right to get a monopoly for tinkering with Mother Nature’s products.

At issue in the case of Association for Molecular Pathology v. Myriad Genetics (docket 12-398) is whether Myriad was legally entitled to a patent on isolated fragments of DNA — naturally occurring human genes — that were extracted from blood for a laboratory search for evidence suggesting a risk in women of hereditary breast or ovarian cancer.

On a practical level, the Court seemed to be worried about two conflicting possibilities: if it clamps down too hard on patent eligibility for experimenting with natural products, it will kill the financial incentive for scientific innovation, but if it expands patent eligibility for such experiments too broadly, it will scare off other inventors who might also make breakthroughs if research were not inhibited by a patent monopoly.

Choosing between two alternative concerns appeared to be challenging enough that some of the Justices went looking for ways to avoid going too far in either direction, to find a way to decide this case that doesn’t settle too much too quickly. Before the Court is the simple but profound question: are human genes patentable? The Justices, however, found out quickly just how complex that question can be, and how difficult it will be to come up with a complete answer.

Justice Samuel A. Alito, Jr., suggested that the Court might be wise not to try to decide the whole issue of when manipulating nature can be treated as human invention. Chief Justice John G. Roberts, Jr., commented that the Court might be asking the wrong patent question at this point, and perhaps should order a look into whether the Myriad patents should fail because its method of extracting genes would have been obvious to any trained scientist in the field.

But, if there was one inclination that emerged most strongly on the legal side of the argument, it is that the Court is not going to accept the recommendation of Myriad’s attorney that it dilute the long-standing doctrine that a product of nature is simply not eligible for a patent. Washington attorney Gregory A. Castanias, arguing for Myriad, dropped several broad hints that the exclusion had lost its utility in modern science.

Another inclination, though it was not as firmly established in the argument, was not to write an opinion as broadly as suggested by the attorney for the challengers to Myriad’s patents, Christopher A. Hansen, an American Civil Liberties Union lawyer from New York. Hansen wanted a flat declaration that human genes are not patentable — period. The Justices who pressed him closely left the impression that the suggestion was both too simple, and possibly too inhibiting for inventors and their financial backers.

U.S. Solicitor General Donald B. Verrilli, Jr., asked the Court to go almost as far as Hansen did on naturally occurring gene extraction, but urged the Court to allow the patenting of synthetic DNA molecules — something that Justice Anthony M. Kennedy cleverly described as “economy-class gene.” (Myriad’s challengers oppose patents even on synthetic gene combinations.)

No one on the Court was in doubt that Myriad would have been entitled to a patent if it found some unique way to make use of the genes it has isolated, but the Justices drew a sharp distinction between creative applications and the core natural item, the gene itself. But that is a legal distinction, between a natural product and its uses, and the Myriad case in some ways involves a patent that sort of straddles the two.

With Justices Stephen G. Breyer and Sonia Sotomayor displaying what appeared to be the nearest approximation of some scientific understanding of human genetics, the other Justices who took an active part generally tried to stay away from those specifics, and to find ways to simply describe what Myriad’s scientists had done with its extraction of human genes.

Chief Justice Roberts came up with a simplification that other Justices found quite useful. All that Myriad had done, he suggested, was taking a string of molecules out of the body, and “snipping” it off.

But the Court got even more comfortable stepping away from any scientific analysis, and pondering examples of how to turn a product of nature into something that would benefit society. There were two that captivated the Court: the baseball bat that is something that comes from nature — a tree — but becomes something very different, and the leaf or sap of an Amazonian plant that has curative potential for human disease.

The Justices worked, and at times over-worked, those examples, but it was clear that they were regarded as highly serviceable ways to think about Myriad’s patents. And that might well be ominous for Myriad, since each of the examples made highly vivid the existence of two products: the natural one, and then something else that someone had the genius to create out of it. The tree can’t be patented, and neither can the plant while it grows in the forest in the Amazon, the Justices kept pointing out.

Myriad, of course, has argued that it did invent something with the extracted genes, but its lawyer struggled on Monday to try to differentiate that from the tree and the bat, and the Amazon plant and its sap.

On Thursday, the justices met for their May 23 conference; John Elwood's Relist Watch compiles the petitions that were relisted for this conference.

Major Cases

Department of Commerce v. New York(1) Whether the district court erred in enjoining the secretary of the Department of Commerce from reinstating a question about citizenship to the 2020 decennial census on the ground that the secretary’s decision violated the Administrative Procedure Act, 5 U.S.C. 701 et seq; (2) whether, in an action seeking to set aside agency action under the APA, a district court may order discovery outside the administrative record to probe the mental processes of the agency decisionmaker -- including by compelling the testimony of high-ranking executive branch officials -- without a strong showing that the decisionmaker disbelieved the objective reasons in the administrative record, irreversibly prejudged the issue, or acted on a legally forbidden basis; and (3) whether the secretary’s decision to add a citizenship question to the decennial census violated the enumeration clause of the U.S. Constitution.

Lamone v. BenisekIn case in which the plaintiffs allege that a Maryland congressional district was gerrymandered to retaliate against them for their political views: (1) whether the various legal claims articulated by the three-judge district court are unmanageable; (2) whether the three-judge district court erred when, in granting plaintiffs’ motion for summary judgment, it resolved disputes of material fact as to multiple elements of plaintiffs’ claims, failed to view the evidence in the light most favorable to the non-moving party, and treated as “undisputed” evidence that is the subject of still-unresolved hearsay and other evidentiary objections; and (3) whether the three-judge district court abused its discretion in entering an injunction despite the plaintiffs’ years-long delay in seeking injunctive relief, rendering the remedy applicable to at most one election before the next decennial census necessitates another redistricting.

The American Legion v. American Humanist Association(1) Whether a 93-year-old memorial to the fallen of World War I is unconstitutional merely because it is shaped like a cross; (2) whether the constitutionality of a passive display incorporating religious symbolism should be assessed under the tests articulated in Lemon v. Kurtzman, Van Orden v. Perry, Town of Greece v. Galloway or some other test; and (3) whether, if the test from Lemon v. Kurtzman applies, the expenditure of funds for the routine upkeep and maintenance of a cross-shaped war memorial, without more, amounts to an excessive entanglement with religion in violation of the First Amendment.

Gamble v. United StatesWhether the Supreme Court should overrule the “separate sovereigns” exception to the double jeopardy clause.

Recent Decisions

Herrera v. Wyoming Wyoming’s statehood did not abrogate the Crow Tribe’s 1868 federal treaty right to hunt on the “unoccupied lands of the United States”; the lands of the Bighorn National Forest did not become categorically “occupied” when the forest was created.

Merck Sharp & Dohme Corp. v. Albrecht “Clear evidence” that the Food and Drug Administration would not have approved a change to a drug’s label – thus pre-empting a state-law failure-to-warn claim – is evidence showing that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning; the question of agency disapproval is primarily one of law for a judge to decide.

Current Relists

Conference of May 23, 2019

al-Alwi v. Trump (1) Whether the government’s statutory authority to detain Moath Hamza Ahmed al-Alwi has unraveled; (2) whether, alternatively, the government’s statutory authority to detain al-Alwi has expired because the conflict in which he was captured has ended; and (3) whether the Authorization for Use of Military Force authorizes, and the Constitution permits, detention of an individual who was not “engaged in an armed conflict against the United States” in Afghanistan prior to his capture.

Box v. Planned Parenthood of Indiana and Kentucky Inc. (1) Whether a state may require health-care facilities to dispose of fetal remains in the same manner as other human remains, i.e., by burial or cremation; and (2) whether a state may prohibit abortions motivated solely by the race, sex or disability of the fetus and require abortion doctors to inform patients of the prohibition.

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On March 30, Justice Clarence Thomas spoke with former clerk Brittney Lane Kubisch and Pepperdine University President-elect James Gash at Pepperdine University School of Law. Thomas told the audience that he had no plans to retire from the Supreme Court.